Drugmakers have increasingly been pursuing the accelerated approval route after 2010, but the regulatory pathway has nonetheless been subject to a fresh wave of criticism from researchers, with the Journal of the American Medical Association (JAMA) most recently raising concerns.
JAMA Study Continues Wave Of Accelerated Approval Criticism Amid Expansion Of Pathway
Sponsors are increasingly using the accelerated approval pathway, but research continues to be critical about its aspects.

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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.